(31 days)
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No
The description focuses on hardware components (scintillator crystals, photomultiplier, shielding) and basic data processing (cpm, dpm calculation) without mentioning any AI/ML algorithms or capabilities.
No.
The device is a laboratory instrument used to count gamma radiation from radiolabelled reagents for diagnostic assays, not to directly treat or diagnose a disease in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for use "as part of diagnostic radioassay or radioimmunoassay methods."
No
The device description clearly outlines hardware components including a bench-top gamma radiation counter, scintillator crystals, photomultipliers, a lead-tin-copper shield, and read-out electronics, in addition to the software.
Based on the provided information, the SSMPD is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used "as part of diagnostic radioassay or radioimmunoassay methods." These methods are performed on biological samples (in vitro) to aid in diagnosis.
- Device Description: The device measures gamma radiation from "radiolabelled reagents" in "sample tubes." This aligns with the typical use of IVD devices in laboratory settings for analyzing samples.
- Intended User / Care Setting: The intended users are "operators qualified to measure gamma-ray emissions from radiolabelled reagents" in a "clinical laboratory." This is a common setting for IVD testing.
- Predicate Device: The listed predicate device, K770088 Gamma 5500 Counting System, is also a gamma counter used in clinical laboratories for diagnostic purposes, further supporting the classification of the SSMPD as an IVD.
While the document doesn't explicitly use the term "In Vitro Diagnostic" in the intended use statement itself, the description of its function and application within diagnostic radioassay and radioimmunoassay methods clearly places it within the scope of IVD devices.
N/A
Intended Use / Indications for Use
The SSMPD is intended as a general use clinical laboratory gamma radiation counter. The SSMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).
Product codes
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Device Description
The ssMPD is a twelve sample, bench-top gamma radiation counter that can be used to measure counts per minute and calculate disintegrations per minute emitted by multi-photon emission isotopes, including 125I. In volumes of 0.05 to 2.0 mls contained in 12 mm x 75 mm or 13 mm x 100 mm sample tubes disintegrations are measured over the range of 1 to 10^6 dpms. The sample tubes must be capped to minimize the possibility of contaminating the detector chamber.
The full detector assembly is a twin detector system consisting of two scintillator crystals--each coupled to a high resolution planar photomultiplier. The entire detector is encased in a composite lead-tin-copper shield to minimize environmental background. In addition to permitting efficient counting of gamma emitters, the sample holder acts as a separator to reduce crosstalk within the twin scintillator detector assembly.
The complete SSMPD system is comprised of a standalone SSMPD connected directly to a personal computer (PC) configured with SSMPD read-out electronics, MPDATA™ control and data logger software, and optionally, a printer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operators qualified to measure gamma-ray emissions from radiolabelled reagents
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2320 Beta or gamma counter for clinical use.
(a)
Identification. A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
-17000
SAFETY AND EFFECTIVENESS SUMMARY IX.
BioTraces Inc.
10517-A West Drive Fairfax, VA 22030
tel: (703) 273-6941 Office: fax: (703) 273-6968
Premarket Notification [510(k) ] Summary
| Summary submitted by:
Address:
Telephone:
Facsimile:
Contact person:
Summary prepared on: | E. James Wadiak, President
BIOTRACES INC., 10517-A West Drive, Fairfax, VA, 22030
(703) 273-6941
(703) 273-6968
E. James Wadiak, President
July 8, 1996 |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name:
Common/Usual Name:
Classification Name: | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (SSMPD)
Gamma Scintillation Counter
Counter (Beta, Gamma) For Clinical Use |
| Substantial Equivalence: | The ssMPD is substantially equivalent in specifications and
principles of operation to the Gamma 5500 Counting System
(originally listed as Gamma 4000 Scintillation Counter),
510(k) Number: K770088, manufactured by Beckman
Instruments, Inc., Scientific Instruments Division, Irvine,
California 92713. |
| Description: | The ssMPD is a twelve sample, bench-top gamma radiation
counter that can be used to measure counts per minute and
calculate disintegrations per minute emitted by multi-photon
emission isotopes, including 125I. In volumes of 0.05 to 2.0
mls contained in 12 mm x 75 mm or 13 mm x 100 mm sample
tubes disintegrations are measured over the range of 1 to 106
dpms. The sample tubes must be capped to minimize the
possibility of contaminating the detector chamber. |
| | The full detector assembly is a twin detector system consisting
of two scintillator crystals--each coupled to a high resolution
planar photomultiplier. The entire detector is encased in a |
Section IX - 1
1
| | composite lead-tin-copper shield to minimize environmental
background. In addition to permitting efficient counting of
gamma emitters, the sample holder acts as a separator to
reduce crosstalk within the twin scintillator detector assembly. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The complete SSMPD system is comprised of a standalone
SSMPD connected directly to a personal computer (PC)
configured with SSMPD read-out electronics, MPDATA™
control and data logger software, and optionally, a printer. |
| Intended Use: | The SSMPD is intended as a general use clinical laboratory
gamma radiation counter. The SSMPD is designed for use by
operators qualified to measure gamma-ray emissions from
radiolabelled reagents within particular energy bands or energy
regions of interest (ROI) as part of diagnostic radioassay or
radioimmunoassay methods. The standard quantitative units
of measure reported are the measured count per minute (cpm)
and the calculated disintegrations per minute (dpm). |
| Device Comparison: | Both the SSMPD and the Gamma 5500 Counting System
utilize a 2" inorganic scintillating crystal, a photomultiplier
tube (PMT), various electronic systems to amplify, scale, and
analyze pulse heights, and a variety of output formats and
devices for display of results to quantify gamma emissions in |
a sample.
However, the SSMPD uses two identical CaF2(Eu) scintillator crystals with PMT read-outs as a detector whereas the Gamma 5500 Counting System uses one Nal(T)) scintillator crystal with PMT read-out. Both inorganic scintillator crystals have emission maximums that are well matched to the sensitivity of the bialkali photocathode PMTs used in the ssMPD and a refractive index that is close to that of most PMT windows and optical coupling compounds. The photoelectron yield of Nal(Tl) produces the highest signal of all known scintillators and is twice that of CaF2(Eu). However, the light yield of CaF2(Eu) is easily within an acceptable range of performance.
NaI(Tl) is susceptible to mechanical, thermal, and radiation damage. It is hydroscopic and colors over time and must be housed in a sealed environment. It is toxic. In addition, it is soft and cannot be machined easily. CaF (Eu) is not
2
susceptible to mechanical, thermal, and radiation da is transparent and insoluble in water and mos solvents, permitting radioactive samples in soluti placed in direct contact with the crystal. It is nonaddition, it is hard and can be machined easily.
The ssMPD performs pulse shape as well as pul analysis in software and hardware to increase the spe pulse acceptance and rejection and lower the envir background. The Gamma 5500 Counting System pulse height analysis.
The ssMPD uses a 2" primary lead shield and a s composite lead-tin-copper shield to minimize back events contributed by the lead itself. The Gamm Counting System utilizes 1" of lead shielding secondary composite shield.